Program Manager III, Companion Diagnostics

Thermo Fisher Scientific • Carlsbad, CA

1d • Onsite

About The Position

The Program Manager III manages defined workstreams contributing to next-generation sequencing (NGS)-based oncology companion diagnostic programs. The role coordinates work across scientific, clinical, regulatory, quality, and operational teams; maintains plans for assigned scope; and resolves routine execution issues. Work is performed within established program objectives and governance. Decisions affecting overall program direction, partner commitments, or functional priorities are brought to the program or functional leader.

The position is based in Carlsbad, California. Relocation assistance is not provided. Candidates must be legally authorized to work in the United States without sponsorship and must pass a comprehensive background check, including a drug screen.

Requirements

• Bachelor’s degree in molecular biology, genetics, biochemistry, biomedical engineering, engineering, or a related scientific or technical discipline.
• At least 5 years of related experience with a bachelor’s degree, or at least 3 years with an advanced degree or equivalent work experience.
• Experience managing project workstreams or coordinating cross-functional activities in a regulated product-development environment, such as diagnostics, IVD, medical devices, clinical testing, biotechnology, or pharmaceuticals.
• Experience maintaining plans and delivering defined project activities through one or more stages of development, validation, regulatory submission, launch, or lifecycle management.
• Working knowledge of regulated product-development practices, including design controls, risk management, traceability, verification and validation, and quality systems.
• Experience using program-management tools to track schedules, dependencies, risks, and resources.
• Strong organization, follow-through, and attention to detail.
• Clear written, verbal, and presentation skills.
• Sound judgment in prioritizing work and resolving day-to-day issues.
• Ability to coordinate effectively across scientific, clinical, regulatory, quality, and operational teams.
• Ability to recognize risks and dependencies, recommend practical actions, and escalate decisions when needed.
• Ability to apply established methods and procedures while adapting plans to changing project information.
• Legal authorization to work in the United States without sponsorship.
• Ability to pass a comprehensive background check, including a drug screen.

Nice To Haves

• Advanced degree.
• PMP or equivalent program-management certification.
• Familiarity with oncology, precision medicine, NGS, molecular diagnostics, companion diagnostics, or a related clinical testing platform.
• Experience coordinating work with external partners, vendors, clinical teams, or CROs.

Responsibilities

• Manage workstream plans, including activities, deliverables, dependencies, milestones, and acceptance criteria, within agreed objectives and scope.
• Coordinate contributors across assay and reagent development, bioinformatics and software, clinical and analytical validation, regulatory affairs, quality, manufacturing, supply chain, commercial, and customer support.
• Translate approved requirements into workstream tasks and track progress against the agreed plan.
• Maintain schedules, action items, risks, dependencies, and decision records; identify potential impacts to timing, resources, or quality.
• Prepare concise status updates and review materials highlighting progress, open issues, and decisions needed.
• Coordinate routine information exchange with external partners according to established communication plans and escalate changes to commitments or expectations.
• Track assigned activities involving design controls, risk management, traceability, verification and validation, change control, and regulatory submissions in partnership with Regulatory Affairs and Quality.
• Coordinate assigned clinical or analytical validation activities against approved study plans and program milestones.
• Track budget, forecast, and resource information for assigned work and report variances to the program or functional leader.
• Coordinate assigned launch-readiness or lifecycle activities, including readiness tracking, documentation, and follow-up on team actions.
• Identify and resolve day-to-day execution issues with relevant team members; recommend options and escalate issues affecting approved scope, milestones, quality, or partner commitments.
• Apply program-management practices and relevant business or technical knowledge to improve execution of assigned work.
• Adapt workstream plans to approved changes in data, requirements, or priorities and communicate impacts to affected contributors.

Benefits

• Competitive remuneration.
• Variable annual incentive plan bonus may be available based on company, team, and/or individual performance.
• Choice of national medical and dental plans and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off and 10 paid holidays annually.
• Paid parental leave: 3 weeks for bonding and 8 weeks for caregiver leave.
• Accident and life insurance.
• Short- and long-term disability in accordance with company policy.
• 401(k) retirement savings plan.
• Employees’ Stock Purchase Plan offering eligible colleagues the opportunity to purchase company stock at a discount.
• Career and development prospects.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior